Pfizer's Xtandi Label Expansion Filing Gets Priority Review

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Pfizer, Inc. PFE and partner Astellas announced that the FDA has accepted the supplemental New Drug Application (sNDA) looking for label expansion of cancer drug, Xtandi in men with metastatic hormone-sensitive prostate cancer and granted priority review designation to it.

The sNDA was based on data from the phase III ARCHES study, data from which demonstrated that Xtandi in combination with androgen deprivation therapy (“ADT”) significantly reduced the risk of radiographic progression or death by 61% compared to ADT alone. The sNDA is also supported by data from an Astellas-supported study, ENZAMET, which also met the primary endpoint of overall survival. With the FDA granting priority review designation to the sNDA, a decision is expected in the fourth quarter. A similar application is also under review in the EU and Japan

Pfizer’s shares have declined 20.2% this year so far compared with a decline of 2.2% for the industry.



Xtandi is already approved to treat metastatic and non-metastatic castration-resistant prostate cancer.  If data from ARCHES is approved to be included in the label of Xtandi, it can treat a broader prostate cancer patient population.

Xtandi was added to Pfizer’s portfolio with the acquisition of Medivation in September 2016. While Pfizer sells Xtandi in the United States in partnership with Astellas, the latter owns the marketing right outside the U.S. markets. Pfizer recorded Xtandi alliance revenues of $369 million in the first half of 2019.

Xtandi is also being evaluated in late-stage studies for hormone-sensitive prostate cancer as well as in mid-stage studies for advanced breast cancer and hepatocellular carcinoma.

In a separate press release, Pfizer said it is investing half a billion dollars for expanding its state-of-the-art gene therapy manufacturing facility in Sanford, NC. The $500 million investment will add more capacity at the Sanford plant, which makes gene therapies as well as Pfizer’s popular vaccine Prevnar 13. It also has other vaccines in development.

Pfizer currently carries a Zacks Rank #5 (Strong Sell). Some better-ranked large-cap pharma stocks are Roche Holding AG RHHBY, Sanofi SNY and Merck MRK. While Roche sports a Zacks Rank #1 (Strong Buy), Sanofi and Merck carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Shares of Roche have gained 11.9% this year so far. Earnings estimates for 2019 have risen 0.8% while that for 2020 have increased 2% over the past 30 days.

Sanofi’s earnings estimates have increased 0.3% and 0.9%, respectively, for 2019 and 2020 over the past 30 days.

Merck’s stock is up 13.7% this year so far. Its earnings estimates have risen almost 3.2% for 2019 and 1.1% for 2020 over the past 30 days.

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